Decision No. 44/1999/QĐ-BNN/KHCN on issuing the standard "General Requirements for Agricultural Testing Laboratories"

Pursuant to …;

Regarding the issuance of the standard "General Requirements for Agricultural Testing Laboratories"

 Industry

__________________ 

THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to Decree No. 73/CP dated November 1, 1995 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decree No. 86/CP dated December 8, 1995 of the Government on the division of responsibilities for state management of product quality;

Considering the proposal of the Director of the Science and Technology Department - CLSP,

DECISION:

Article 1. Now we issue the standard 10 TCN 382 - 99: "General Requirements for Agricultural Testing Laboratories".

Article 2. THIS DECISION SHALL TAKE EFFECT 15 DAYS FROM THE DATE OF SIGNATURE.

Article 3. The Heads of the Office, Directors of the Science and Technology Department - CLSP, Leaders of related organizations and individuals are responsible for implementing this Decision./.

STANDARD GENERAL REQUIREMENTS

FOR AGRICULTURAL TESTING LABORATORIES 100 TCN 382 – 99
(Issued together with Decision No. 44/1999/QD-BNN-KHCN dated February 27, 1999)

I. Introduction:

This standard is developed based on TCVN 5958 - 95.

This standard specifies general requirements that testing laboratories must comply with in all their activities, and it also applies to the evaluation and recognition of agricultural testing laboratories.

II. Management Organization:

2.1. Testing laboratories must have legal personality and be organized and operated in accordance with the requirements of this standard.

2.2. Testing laboratories must:

Have competent management staff and technical staff with the necessary expertise to fulfill assigned tasks.

Have an organizational structure suitable to ensure that no member of the laboratory is subjected to any pressure that may affect the quality of their professional work.

Define responsibilities, authorities, and relationships between employees and laboratory leadership.

Supervise procedures, analytical methods, and result evaluations through personnel with appropriate expertise.

Have a technical manager responsible for all technical activities, including equipment management and maintenance.

Have a quality manager responsible for the quality system and its implementation.

III. Personnel:

3.1. Testing laboratories must have sufficient personnel with the necessary professional qualifications and technical experience to perform assigned functions and tasks (as stipulated in state job titles).

3.2. Laboratory personnel must be regularly trained and educated to enhance their professional qualifications.

3.3. Testing laboratories must maintain records of the qualifications, skills, and experience of personnel to plan training and education programs.

IV. Quality System, Inspection, and Review:

4.1. Testing laboratories must establish and maintain a quality system appropriate to the type, scope, and volume of testing activities assigned to them.

4.2. Quality Manual: Testing laboratories must develop a quality manual according to the provisions of Section 4.3 of TCVN 5958 - 1995.

4.3. Laboratories must schedule regular reviews of their activities to determine whether they comply with the requirements of the quality system. Reviews must be conducted by trained personnel with adequate qualifications, preferably independent from the activities being reviewed. When reviewing, if there is any doubt about the accuracy or validity of test results, the laboratory must immediately notify customers whose work may be affected in writing.

4.4. A quality system that has been accepted and applied to meet the requirements of this standard must be reviewed by management at least once a year to ensure continued suitability and effectiveness, as well as to make necessary changes or improvements.

4.5. All findings during inspections or reviews, as well as corrective actions, must be documented. The quality manager must ensure that these tasks are completed within the agreed timeframe.

4.6. In addition to regular inspections, testing laboratories must ensure the quality of results provided to customers through continuous checks, including:

a) Internal quality control systems, using statistical techniques when available.

b) Proficiency testing or inter-laboratory comparisons.

c) Regular use of certified reference materials or secondary standards to control quality in the laboratory.

d) Repeated testing using the same method or different methods.

e) Retesting of retained samples.

k) Examination of the correlation of results with different characteristics of the subject.

V. Facilities and Environment:

5.1. Testing facilities and environment must ensure that they do not affect the quality of tests and high-precision equipment.

5.2. Testing laboratories must have equipment to control environmental conditions affecting test results.

5.3. Testing laboratories need to implement appropriate measures to ensure industrial hygiene in the laboratory.

5.4. Equipment:

5.4.1. Testing laboratories must be equipped with basic minimum equipment categories to accurately conduct tests (a separate list is provided for each specialty area).

5.4.2. All equipment must be properly maintained and serviced regularly to prevent errors during testing.

5.4.3. All testing laboratory equipment, including standards and specimens, must have tracking records as specified in Section 8.4 of TCVN 5958 - 1995.

5.4.4. All measuring and testing equipment that affects the accuracy or validity of testing work must be calibrated or verified before use and re-calibrated or re-verified every six months or annually.

VI. Test Methods:

6.1. Testing laboratories must use standardized test methods published in Vietnamese standards, international standards, or industry standards (including sampling, sample preparation, sample retention...).

6.2. When test methods have not yet been established as standards, methods published by reputable technical organizations or officially written and widely used in domestic and international research institutions can be used.

In necessary cases, testing laboratories must agree in writing with customers regarding the use of test methods that have not yet been established as standards.

VII. Sample Management:

7.1. The laboratory must have appropriate means to prevent confusion and damage to test samples during preparation for testing, storage, and receipt and retention of samples by staff must strictly follow relevant guidelines related to test samples. Test samples must be stored under safe environmental conditions, and if necessary, they must be controlled and fully documented.

7.2. The laboratory must comply with procedures for receiving, storing, and disposing of samples as prescribed.

8. Records:

8.1. The laboratory must maintain a record system suitable for its specific conditions and comply with all current regulations.

8.2. Stored records must be coded to ensure confidentiality and can be retrieved easily when necessary.

9. Certificates and Test Reports:

9.1. Test results must be reported clearly, accurately, and objectively in accordance with testing method guidelines. Typically, results need to be reported in a test report or a test result certificate and should include all necessary information about the sample.

9.2. Test result reports must at least include the following information:

a) Title: For example, "Test Result Report," "Quality Certificate," etc.

b) Name and address of the laboratory.

c) Serial number of the test result report.

d) Name and address of the customer.

e) Sample identification code.

g) Date of sample receipt, date of testing, and date of sampling.

h) Testing method used, or a description of the method used in a box with an official standard.

i) Test results and comments.

k) Signature and position of the person responsible for the content of the certificate or test result report and the date of signature.

l) Announce (at the end of the page) the validity of the test result report and that it may not be copied without the written consent of the laboratory.

9.3. If the test result report includes test results performed by another laboratory, these results must be clearly noted.

9.4. The format of the test result report must be consistent for each field of testing to ensure scientific accuracy and clarity. The format must be carefully designed for each test conducted. Titles must meet high standards of standardization.

9.5. Any amendments or supplements to issued test result reports must be made only in the form of additional documentation.

9.6. The laboratory must ensure that test results are communicated to customers in a convenient and timely manner.

10. Receiving and Processing Information:

10.1. The laboratory must have provisions to address complaints from customers and relevant authorities regarding laboratory activities.

10.2. The laboratory must promptly implement corrective measures for complaints within its scope of operations and responsibilities in accordance with the provisions set forth in this standard.

10.3. The laboratory must retain complete records of complaints and the corrective measures taken.